PlainRecalls
FDA Drug Moderate Class II Terminated

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

Reported: May 16, 2018 Initiated: April 26, 2018 #D-0801-2018

Product Description

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
52 vials
Distribution
AL, CA, FL, MI, SC, TX
Location
Tampa, FL

Frequently Asked Questions

What product was recalled?
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL. Recalled by Coast Quality Pharmacy LLC. Units affected: 52 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on May 16, 2018. Severity: Moderate. Recall number: D-0801-2018.